Assessing the adequacy of information and consent: Negus v Guy’s and St Thomas’ NHS Foundation Trust [2021] EWHC 643 (QB).

Summary
In this article, David Roderick discusses (a) the recent case of Negus v Guy’s and St Thomas’ NHS Foundation Trust [2021] EWHC 643 (QB); (b) relevant criteria for assessing the adequacy of information and/or consent illustrated by the reported cases since Montgomery v Lanarkshire Health Board [2015] UKSC 11, and (c) the new General Medical Council guidance to doctors on decision making and consent.

To what degree should an advice or consent discussion address the permutations of alternative treatments, the technical detail of variant treatments and their respective risks, and any contingencies arising during the course of treatment?

Discussion
It is now uncontroversial that obtaining informed consent for a medical procedure requires a discussion between a doctor and patient of the material risks involved in the treatment; of the possible alternative or variant treatments, and the risks inherent in those alternatives. However, each such discussion will naturally be fact specific, and the extent of the information required so as to constitute adequately informed consent remains ripe for dispute.

In the recent case of Negus v Guy’s and St Thomas’ NHS Foundation Trust [2021] EWHC 643 (QB) (19 March 2021), a claim was pursued on behalf of TN, in relation to aortic valve replacement surgery. In March 2014, TN underwent implantation of a 19mm mechanical valve. That implant proved insufficient, and resulted in a ‘patient-prosthesis mismatch’, a type of cardiac dysfunction. Therefore, in March 2015, TN underwent re-do surgery to insert a larger valve which required an aortic root enlargement procedure (“ARE”). Difficulties arose during this second operation, TN developed complications during post-operative recovery, and her condition then deteriorated leading to her death from heart failure in January 2020.

The Claimants’ case was that the first surgery in 2014 was negligent because a larger sized valve should have been implanted, even though that would have required an ARE. Further, and which is the focus of this article, that there had been a negligent failure to properly advise TN as to the risks arising from the implantation of a smaller valve, and a failure to advise as to the possibility of a larger valve and performing an ARE as a variant treatment. The Claimants’ contended that the re-do operation and TN’s subsequent deterioration and death would have been avoided had an ARE been performed on 5 March 2014 and a larger valve initially implanted. The agreed issues requiring determination were fourfold:

i) Was it negligent to implant a 19mm mechanical reduced valve during TN’s surgery on 5 March 2014?

ii) Alternatively, was there a negligent failure to explain, as part of the consent process, that the largest possible valve should be implanted to avoid the risk of cardiac dysfunction although this would involve an ARE, which was more complicated and involved higher risk? If so, would TN have opted to undergo ARE?

iii) If an attempt had been made to implant a larger valve, would TN have suffered the same complications that she did during surgery on 18 March 2015?

iv) Did the failure to implant a 21mm valve cause the cardiac dysfunction requiring re-do surgery on 18 March 2015, with associated complications, and TN’s subsequent death on 29 January 2020?

In relation to issue i) it was concluded, essentially on the assessment of the expert evidence, that the decision to initially implant a 19mm valve was a reasonable exercise of judgement. That was determined on an application of the well-known test that a medical practitioner is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art with the court being satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis Bolam v Friern Hospital Management Committee [1957] 1 W.L.R. 582 and Bolitho v City and Hackney Health Authority [1998] AC 232.

For the purposes of this article therefore, issue ii) is obviously the most relevant. In relation to obtaining informed consent, different considerations of course apply, following Montgomery v Lanarkshire Health Board [2015] UKSC 11. The arguably paternalistic former dynamic within the doctor/patient relationship has now shifted towards the enabling of patient autonomy. A patient is entitled to decide which, if any, of the available forms of treatment to undergo, and consent must be obtained before treatment is undertaken. The scope of this duty is to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.

The test of materiality in respect of risk is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it. Furthermore, the significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient (Montgomery, paragraphs 87 and 89).

Developments since Montgomery
Therefore, before turning to the assessment of the adequacy of the information and consent process in Negus, it is useful to outline the following decisions in respect of obtaining consent and/or the provision of information since Montgomery. The cases illustrate what adequately informed consent might or might not be:

• In Spencer v Hillingdon NHS Trust [2015] EWHC 1058, the claimant developed deep vein thrombosis and pulmonary emboli after hernia surgery. He did not seek treatment immediately because he had not been advised of the risk of those complications or of symptoms that might indicate them. In respect of providing information and in light of the decision in Montgomery, the Judge “added a gloss” to the Bolam test and held that the duty of care was to advise and inform patients of anything which the ordinary sensible patient would be justifiably aggrieved not to have been told when fully appraised of its significance.

• In Thefaut v Johnston [2017] EWHC 497 (QB); [2017] Med. L.R. 319, incomplete and substantially inaccurate advice was given to the claimant concerning the anticipated success rate for surgery to alleviate back and leg pain, and the surgeon neglected to advise the claimant on the inherent risk that the surgery could exacerbate her condition. Further, the surgeon had risked confusion by not including in the post-consultation letter the option of not undergoing surgery at all. The factual matrix in Thefaut perhaps represented a relatively clear-cut example of a failure to obtain informed consent.

• Webster v Burton Hospitals NHS Foundation Trust [2017] EWCA Civ 62, concerned a failure by a consultant to properly advise an expectant mother of the risks and uncertainties of earlier delivery and delayed labour. The claim was dismissed at first instance, it being held that, applying Bolam, a responsible body of obstetricians would not have departed from the conservative treatment that was deployed. Applying Montgomery, the Court of Appeal held that the obstetrician should have told the mother of anomalies and complications which could not be avoided by earlier delivery, but also the increased risk of perinatal mortality, including antepartum mortality, even if based on a very small statistical base. The consultant should also have told the mother that there was emerging but recent and incomplete material showing increased risks of delaying labour in cases with her combination of features. Had she been told all that information, the claimant would have elected early delivery, which would have avoided brain injury to the child. Importantly, that conclusion was supported by the claimant’s background, which included a university degree in nursing, and her willingness to take responsibility for her pregnancy.

• In Diamond v Royal Devon & Exeter NHSFT [2017] EWHC 1495 (QB), while the claimant failed on causation, she had not been properly informed about the options of mesh-based or alternatively suture repair of a hernia. The consultant did not ask if the claimant intended to become pregnant in the future (relevant because of the adverse risks for pregnancy following mesh-based repair) or advise as to the possibility of a suture repair (without the same adverse risks, but which carried a high risk of failure).

• Bayley v George Eliot Hospital NHS Trust [2017] EWHC 3398 (QB) was a claim on the basis that doctors had failed to inform a patient about all reasonable alternative treatments for her condition. Following Montgomery, it was held that the duty is limited to “reasonable alternatives”, and identifying what was a reasonable alternative treatment had to be a decision which was sensitive to the particular facts and circumstances of any given case. Factors relevant to the consideration might be the availability of the treatment, the extent to which it was known about, and the lack of published journal articles in the UK about research into it.

• In Plant v El-Amir [2020] EWHC 2902 (QB) in relation to eye surgery, the surgeon failed to inform the partially sighted claimant: (a) of published data which did not support reasonable outcomes for patients in her circumstances, or (b) give her adequate information from which she could have established that the procedure had significant risks.

Unsurprisingly perhaps, the cases do not result in a simple catalogue of generally applicable criteria suitable for every case crossing the clinical negligence lawyer’s desk. However, some particularly relevant factors can be identified:

• It is very likely to be necessary to include certain information about the dichotomous choice between two variant treatments, or between treatment and no treatment (Diamond, Thefaut, Plant).

• Even very minor or emergent risks are appropriate to discuss (an ordinary patient is likely to be justifiably aggrieved if the significance of even an unlikely possibility is grave (Spencer, Webster)).

• The necessity to include certain information may be heightened by the characteristics of a medically qualified or particularly engaged patient (Webster).

• It may not be unreasonable to fail to discuss a possible alternative where it is an uncommon treatment, with a lack of published research (Bailey).

GMC guidance on decision making and consent
Negus is also one of the first High Court cases on the scope of the content of advice and information since the General Medical Council’s new guidance document ‘Decision making and consent’ came into effect on 9 November 2020. The previous iteration of this advice pre-dated the decision in Montgomery.

The stated intention of the guidance is to help make sure that the doctor has obtained informed consent from the patient, and it expressly advises on ‘what you should tell a patient when talking about risks’. The guidance contains much extremely useful advice which can’t all be cited here; however the most germane points are as follows.

• The guidance acknowledges the appropriateness of a proportionate approach to decision making and consent which will be dependent on the doctor’s judgement about how to apply the guidance given the specific circumstances of each decision. For example, the nature and severity of the patient’s condition and how quickly the decision must be made, and the complexity of the decision, the number of available options and the level of risk or uncertainty associated with any of them, and what is already known about the patient, what they already know about their condition, and the potential options for treating or managing it (Guidance, paragraph 5).

• The guidance also states that information patients must be given will usually include; uncertainties about the diagnosis or prognosis, including options for further investigation; options for treating or managing the condition, including the option to take no action, the nature of each option, what would be involved, and the desired outcome; together with, the potential benefits, risks of harm, uncertainties about and the likelihood of success for each option, including the option to take no action (Guidance, paragraphs 8 to 10).

• Furthermore, with specific reference to discussing benefits and harms, doctors are informed that the following information should usually be included:
  “Recognised risks of harm that you believe anyone in the patient’s position would want to know. You’ll know these already from your professional knowledge and experience.
  The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring. If you know the patient’s medical history, you’ll know some of what you need to share already, but the dialogue could reveal more.
  Risks of harm and potential benefits that the patient would consider significant for any reason. These will be revealed during your discussion with the patient about what matters to them.
  Any risk of serious harm, however unlikely it is to occur” (Guidance paragraphs 21 to 23).

• Additionally, in terms of dealing with uncertainties, the Guidance states that “Some things will become clearer after treatment starts, so you should discuss in advance what the arrangements will be for monitoring the effect of the treatment and reviewing the decision to provide it” (Guidance, paragraph 26).

It is likely that the guidance will be a source of reference in future claims. It can be seen that the guidance reflects the outcome of the some of the cases discussed above: for example, the necessity to discuss even very unlikely risks if serious harm might eventuate, and the requirement to discuss benefits, risks and uncertainties for each available option. That language will be of assistance to a claimant trying to establish a claim for failed consent.

Conversely, the overriding element of professional discretion is maintained by the guidance which expressly validates a doctor exercising their own judgment about how to apply the guidance given the specific circumstances of each decision.

It is not apparent from the judgment in Negus whether the GMC guidance was referred to either in the expert reports or in argument.

The conclusion on information and consent in Negus
Returning to the operative question in Negus: was there a negligent failure to explain, as part of the consent process, that the largest possible valve should be implanted to avoid the risk of cardiac dysfunction even though this would involve an ARE? The material findings and conclusions reached by Mrs Justice Eady were that:

• TN had been properly consented in relation to the risks and benefits of aortic valve replacement surgery, and in addition that discussion had included the type of valve to be inserted, as a choice was to be made between a mechanical valve which is made from synthetic material (requiring blood-thinning medication for life), and tissue valves (no medication, but likely to require replacing if inserted in younger patients). The consultant knew that TN, having been a nurse, had some knowledge of the different types of valves.

• An ARE procedure, to be able to fit a larger valve, is a relatively rare procedure. The actual maximum size of valve for a patient can only be determined intraoperatively, and there are different brands and designs of valves, leading to different positioning and fit and consequently different levels of risk of complications. However, prior to the operation, the consultant did not discuss with TN the possibility of undertaking an ARE to permit the insertion of a larger prosthetic valve, nor the details of the alternative designs or risks even though the procedure had been in his mind as a possibility in her case.

• The choices about whether to undertake the ARE, or the final valve specification, were ultimately only capable of being determined intra-operatively.

On those bases, Mrs Justice Eady concluded that the surgeon was under a limited duty to warn TN of the possible risk that he might need to undertake an ARE during the valve replacement operation (however, in that scenario, TN would likely have proceeded to surgery and thus causation was not made out). However, the duty did not extend to offering as a reasonable variant the possibility of undertaking an ARE to permit the insertion of a larger prosthetic valve, nor the various possible choices that might arise intra-operatively. This was because those choices involved highly technical decision-making, requiring a specialist-level of understanding and experience which most patients could not reasonably be expected to grasp, the choices would be made intra-operatively, and because it was not common practice amongst cardiothoracic surgeons to include the possibility of ARE when consenting patients.

Conclusion
The claim in Negus failed, and did not in fact benefit from TN’s past knowledge and experience as a nurse, nor her previous interaction engaging with the choice as to what type of valve to use, nor even the fact that the possibility of an ARE procedure had been in the surgeon’s mind prior to surgery. Nevertheless, following the Montgomery line of cases, Negus develops the important factors to look for in assessing whether reasonable alternatives have been adequately discussed:

• A discussion about tangible choices of treatment prior to surgery commencing is more likely to be a requirement, as opposed to choices that might arise out of intraoperative decision making;

• Where a proposed alternative is contra-indicated by patient factors, it may not be unreasonable to fail to discuss a possible alternative (TN’s physiology, for example, was also relevant to the choice of valve and procedure);

• There is a distinction to be drawn between discussing highly technical decision-making requiring a specialist level of understanding and experience (less likely to be unreasonable to leave out of a discussion), and the ambit of ‘reasonable alternatives’ understandable by the ordinary patient.

David Roderick specialises in personal injury, clinical negligence, inquests and employment work, and their related procedural and costs issues. He acts on behalf of both claimants and defendants in serious injury cases, and predominantly on behalf of claimants in clinical negligence actions. Please contact the Clerks for further information.

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